Disease Burden | TAVNEOS® (avacopan)

Patients living with these chronic conditions can face a long journey to diagnosis, a high risk of relapse, treatment-related toxicities, and a diminished quality of life^2-6

Even after diagnosis, patients experience new, severe manifestations⁷

In a longitudinal study by the Vasculitis Clinical Research Consortium, 26% of patients with established GPA and 19% of patients with established MPA developed new organ- or life-threatening manifestations after diagnosis⁷

Reaching remission and reducing risk of relapse are critical measures to optimizing outcomes for patients with GPA and MPA⁸

In a retrospective cohort study of 101 patients with newly diagnosed or relapsing GPA or MPA who were in remission and receiving rituximab (RTX) maintenance, ~1 in 4 patients (24%) experienced a relapse (30 relapses occurred in 24 patients) during the follow-up period (median 1.4 years)⁹

Of the 30 relapses, 73% occurred within the first 2 years⁹

- 57% were major relapses^*

- 43% were minor relapses^†

*Major relapses: Involving ≥1 vital organ and/or a life-threatening manifestation, necessitating new induction therapy.
^†Minor relapses: Not corresponding to major, but requiring mild treatment intensification, addition of a second agent, or continuation of RTX maintenance therapy as was scheduled without additional interventions.

A goal of treatment is to achieve remission.⁵ Remission of GPA and MPA is defined by the ACR/VF guidelines as the absence of clinical signs or symptoms attributed to GPA or MPA, on or off immunosuppressive therapy¹⁰

In patients with GPA or MPA, risk factors for relapse include, but are not limited to:¹¹

PR3-ANCA positivity

History of relapses

Respiratory tract involvement

Discontinuation of therapy

Even at reduced doses, glucocorticoids, often used in standard therapy for GPA and MPA, may pose risks that are exacerbated with long-term use^5,11-13

Some of the toxicities associated with glucocorticoid use are:^14,15

increased risk of infection
new-onset diabetes
cardiometabolic disease
bone disease

ACR = American College of Rheumatology; VF = Vasculitis Foundation.

Learn how TAVNEOS® works in adults with severe active GPA or MPA

Important safety information

Contraindications

Serious hypersensitivity to avacopan or to any of the excipients.

Warnings and Precautions

Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. In the postmarketing setting, vanishing bile duct syndrome (VBDS) as a consequence of liver injury, including cases with a fatal outcome, has been reported. These events occurred predominantly in Japan in patients aged 65 years and older, but VBDS may affect patients of any age or ethnicity who are receiving TAVNEOS. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for 6 months and as clinically indicated thereafter. For patients of Japanese descent, consider more frequent laboratory testing: every 2 weeks after the start of therapy for the first 3 months, followed by laboratory testing every 4 weeks for the next 3 months of treatment, and as clinically indicated thereafter. If a patient receiving treatment with TAVNEOS presents with an elevation in alanine aminotransferase [ALT] or aspartate aminotransferase [AST] to >3 times the upper limit of normal (ULN), evaluate promptly and consider pausing treatment as clinically indicated. If AST or ALT is > 5 times the ULN, or ALT or AST > 3 times the ULN with total bilirubin > 2 times the ULN, or alkaline phosphatase ≥ 2 times the ULN, or if the patient has clinical symptoms such as jaundice or pruritus, discontinue TAVNEOS until TAVNEOS-induced liver injury is ruled out. Immediately and permanently discontinue TAVNEOS if VBDS is suspected. TAVNEOS is not recommended for patients with active, untreated, and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risks and benefits before administering this drug to a patient with liver disease.

Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including 1 serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be readministered unless another cause has been established.

Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life-threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for 6 months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming.

Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in the TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection, or who have been to places where certain infections are common.

Adverse Reactions

The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia.

Drug Interactions

Avoid co-administration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Consider dose reduction of CYP3A4 substrates when co-administering TAVNEOS. Co-administration of avacopan and 40 mg simvastatin increases the systemic exposure of simvastatin. While taking TAVNEOS, limit simvastatin dosage to 10 mg daily (or 20 mg daily for patients who have previously tolerated simvastatin 80 mg daily for at least one year without evidence of muscle toxicity). Consult the concomitant CYP3A4 substrate product information when considering administration of such products together with TAVNEOS.

TAVNEOS is available as a 10 mg capsule.

INDICATION

TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.

Please see Full Prescribing Information and Medication Guide for TAVNEOS.

To report a suspected adverse event, call 1-833-828-6367. You may report to the FDA directly by visiting www.fda.gov/medwatch or calling 1-800-332-1088.

For patients living with severe active ANCA-associated vasculitis (GPA or MPA), disease burden remains high1

Patients living with these chronic conditions can face a long journey to diagnosis, a high risk of relapse, treatment-related toxicities, and a diminished quality of life2-6

In patients with GPA or MPA, risk factors for relapse include, but are not limited to:11

Even at reduced doses, glucocorticoids, often used in standard therapy for GPA and MPA, may pose risks that are exacerbated with long-term use5,11-13